Lessons Learned From the ACURATE IDE Trial for Transcatheter Aortic Valve Replacement Article Swipe
Arturo Giordano
,
Giuseppe Biondi‐Zoccai
,
David J. Cohen
,
Rodrigo Bagur
,
Nicola Corcione
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1002/ccd.70092
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1002/ccd.70092
The recent voluntary withdrawal of the ACURATE neo2 transcatheter aortic valve replacement device by Boston Scientific offers a compelling case study in the complex interplay of device design, clinical evidence, regulatory requirements, and market dynamics in modern structural heart interventions. Despite promising performance in European and Canadian registries, the ACURATE neo2 valve failed to demonstrate non‐inferiority compared with commercially available balloon‐expandable and self‐expanding platforms in the pivotal ACURATE IDE randomized controlled trial. These results, coupled with introduction of a new regulatory requirements by the European notified body ultimately led to the global discontinuation of the platform. This review critically examines the technological characteristics of ACURATE neo2, compares it with other leading TAVR devices, and explores the potential reasons—ranging from clinical to strategic—that may have led to its market exit. Emphasis is placed on the role of randomized trials in assessing new structural therapies, including a discussion of methodological challenges and opportunities for adaptive trial designs. A structured comparison of device features and withdrawal rationales is also provided, highlighting lessons relevant to clinicians, regulators, and industry stakeholders. Ultimately, the ACURATE neo2 experience underscores the need for robust validation strategies, procedural standardization, and adaptive development pathways in a saturated and high‐stakes market. Lessons learned from this platform should inform future innovation in TAVR and broader cardiovascular device development.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1002/ccd.70092
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ccd.70092
- OA Status
- hybrid
- References
- 22
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4413283889
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4413283889Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1002/ccd.70092Digital Object Identifier
- Title
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Lessons Learned From the ACURATE IDE Trial for Transcatheter Aortic Valve ReplacementWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-08-18Full publication date if available
- Authors
-
Arturo Giordano, Giuseppe Biondi‐Zoccai, David J. Cohen, Rodrigo Bagur, Nicola CorcioneList of authors in order
- Landing page
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https://doi.org/10.1002/ccd.70092Publisher landing page
- PDF URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ccd.70092Direct link to full text PDF
- Open access
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
- OA URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ccd.70092Direct OA link when available
- Concepts
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Medicine, Discontinuation, Randomized controlled trial, Valve replacement, Standardization, Clinical trial, Psychological intervention, Intensive care medicine, Surgery, Cardiology, Internal medicine, Nursing, Political science, Law, StenosisTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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22Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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